Clinical trials: Complicated Urinary Tract Infection (cUTI)
Urinary Tract Infections, Pyelonephritis
Safety, Tolerability, and Efficacy of MK-7655 (Relebactam) + Imipenem/Cilastatin Versus Imipenem/Cilastatin Alone for Treating Complicated Urinary Tract Infection (cUTI) (MK-7655-003)
The purpose of this study is to evaluate the efficacy, safety and tolerability of adding 125 mg or 250 mg doses of MK-7655 (relebactam) to imipenem/cilastatin in adults 18 years or older with complicated urinary tract infection…
- Trial name
- NCT01505634
- Testing
- Relebactam 250 mg, Relebactam 125 mg, imipenem/cilastatin 500 mg
- Volunteers
- 302 people
- Sponsor
- Merck Sharp & Dohme LLC
Complicated Urinary Tract Infection, Acute Pyelonephritis
Study to Assess the Efficacy, Safety and Pharmacokinetics of Orally Administered Tebipenem Pivoxil Hydrobromide (SPR994) Compared to Intravenous Ertapenem in Participants With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)
The key purpose of this study is to evaluate the efficacy, safety and pharmacokinetics (PK) of tebipenem pivoxil hydrobromide (TBPM-PI-HBr) compared to intravenous (IV) ertapenem, in participants with complicated Urinary Tract…
- Trial name
- ADAPT-PO (NCT03788967)
- Testing
- TBPM-PI-HBr, Ertapenem, Dummy Infusion
- Where
- 96 sites in United States, Bulgaria and 13 more
- Volunteers
- 1,372 people
- Sponsor
- Spero Therapeutics
Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis
Ceftazidime-Avibactam Compared With Doripenem Followed by Oral Therapy for Hospitalized Adults With Complicated UTIs (Urinary Tract Infections)
The purpose of this study is to evaluate the effects of Ceftazidime Avibactam compared to Doripenem for treating hospitalized patients with complicated urinary tract infections, including acute pyelonephritis
- Trial name
- NCT01599806
- Testing
- Ceftazidime - Avibactam ( CAZ-AVI), Doripenem, Either switch to oral therapy: 500 mg of Ciprofloxacin (oral)
- Where
- 57 sites in United States, Argentina and 15 more
- Volunteers
- 641 people
- Sponsor
- Pfizer
Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis
Ceftazidime-Avibactam Compared With Doripenem Followed by Oral Therapy for Hospitalized Adults With Complicated UTIs (Urinary Tract Infections)
The purpose of this study is to evaluate the effects of Ceftazidime Avibactam compared to Doripenem for treating hospitalized patients with complicated urinary tract infections, including acute pyelonephritis
- Trial name
- NCT01595438
- Testing
- Ceftazidime - Avibactam ( CAZ-AVI), Doripenem, Either switch to oral therapy: 500 mg of Ciprofloxacin (oral)
- Where
- 80 sites in United States, Argentina and 20 more
- Volunteers
- 598 people
- Sponsor
- Pfizer
Healthcare-associated Pneumonia (HCAP), Bloodstream Infections (BSI)
Study of Cefiderocol (S-649266) or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens
This study is designed to provide evidence of efficacy of cefiderocol in the treatment of serious infections in adult patients caused by carbapenem-resistant Gram-negative pathogens.
- Conditions
- Healthcare-associated Pneumonia (HCAP), Bloodstream Infections (BSI), Hospital Acquired Pneumonia (HAP), Complicated Urinary Tract Infection (cUTI)
- Trial name
- CREDIBLE - CR (NCT02714595)
- Testing
- Cefiderocol, Best Available Therapy
- Where
- 85 sites in United States, Brazil and 14 more
- Volunteers
- 152 people
- Sponsor
- Shionogi
Complicated Urinary Tract Infections(cUTI)
Evaluation of the Safety, Tolerability and Pharmacokinetics of TUL108 for Injection in Healthy Participants (SAD/ MAD)
To evaluate the safety, tolerability and pharmacokinetics of single and multiple intravenous (IV) infusion of TUL108 in healthy participants.
- Trial name
- NCT07719257
- Testing
- TUL108
- Where
- China
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Zhuhai United Laboratories Co., Ltd.
Complicated Urinary Tract Infection(cUTI), Including Acute Pyelonephritis(AP)
A Trial of HRS-8427 in the Treatment of Adults With Complicated Urinary Tract Infection, Including Acute Pyelonephritis
The purpose of this study is to evaluate the efficacy and safety of HRS-8427 in patients with complicated urinary tract infection, including acute pyelonephritis.
- Trial name
- NCT06569056
- Testing
- HRS-8427, Imipenem and Cilastatin Sodium
- Where
- China
- Volunteers
- 579 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Complicated Urinary Tract Infections
Sulopenem Followed by Sulopenem-etzadroxil/Probenecid vs Ertapenem Followed by Cipro for Complicated UTI in Adults
This is a prospective, phase 3, randomized, multicenter, double-blind, double-dummy study to compare the efficacy and safety of sulopenem followed by sulopenem-etzadroxil/probenecid versus ertapenem followed by ciprofloxacin for…
- Trial name
- NCT03357614
- Testing
- Sulopenem, Sulopenem-Etzadroxil/Probenecid, Ertapenem
- Where
- 32 sites in United States, Estonia and 3 more
- Volunteers
- 1,395 people
- Sponsor
- Iterum Therapeutics, International Limited
Hospital-acquired Bacterial Pneumonia (HABP), Ventilator-associated Bacterial Pneumonia (VABP)
Study to Assess the Efficacy and Safety of Meropenem and Pralurbactam in Carbapenem-Resistant Enterobacteriaceae Infections
The study will evaluate the efficacy and safety of Meropenem and Pralurbactam versus Best Available Therapy in the treatment of Carbapenem-Resistant Enterobacteriaceae Infections.
- Conditions
- Hospital-acquired Bacterial Pneumonia (HABP), Ventilator-associated Bacterial Pneumonia (VABP), Complicated Intra-abdominal Infection (cIAI), Complicated Urinary Tract Infection (cUTI)
- Trial name
- NCT07089186
- Testing
- Meropenem and Pralurbactam, Best Available Therapy (e.g., colistin, meropenem, tegecycline, amikacinceftezidime-avibatam)
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Complicated Urinary Tract Infection, Acute Pyelonephritis
A Study of Plazomicin Compared With Levofloxacin for the Treatment of Complicated Urinary Tract Infection (cUTI) and Acute Pyelonephritis (AP)
This was a multi-center, multi-national, double-blind, randomized, comparator-controlled study of plazomicin administered intravenously compared with levofloxacin, a standard approved intravenous therapy for complicated urinary…
- Trial name
- NCT01096849
- Testing
- levofloxacin, plazomicin
- Volunteers
- 145 people
- Sponsor
- Achaogen, Inc.
Gram-Negative Bacterial Infections
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Neonates and Infants
The primary purpose of this study is to understand the pharmacokinetics (PK) of single and multiple doses of cefiderocol in children from birth to less than 3 months of age with suspected or confirmed aerobic Gram-negative…
- Trial name
- NCT06086626
- Testing
- Cefiderocol, Standard of Care
- Where
- 4 sites in United States, South Africa and 1 more
- Volunteers
- 30 people
- Sponsor
- Shionogi
Urinary Tract Infections
Cefepime/AAI101 Phase 2 Study in Hospitalized Adults With cUTI
Phase 2, randomised, double-blind, 2-cohort study in hospitalised adults with complicated urinary tract infection (cUTI), including acute pyelonephritis. All study cohorts were randomised in a 2:1 ratio.
- Trial name
- NCT03680612
- Testing
- Cefepime 1G - 2G / AAI101 0.5G - 0.75G, cefepime 1 g or cefepime 2 g
- Where
- 5 sites in Czechia, Hungary and 3 more
- Volunteers
- 45 people
- Sponsor
- Allecra
Gram-negative Bacterial Infections, Bloodstream Infections (BSI)
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Cefiderocol in Hospitalized Pediatric Participants
The primary objectives of this study are: To assess the safety and tolerability of cefiderocol after single-dose administration in hospitalized paediatric participants 3 months to < 18 years of age with suspected or confirmed…
- Conditions
- Gram-negative Bacterial Infections, Bloodstream Infections (BSI), Complicated Intra-abdominal Infection (cIAI), Hospital Acquired Pneumonia (HAP)
- Trial name
- NCT04335539
- Testing
- Cefiderocol, Standard of Care
- Where
- 23 sites in Belgium, Estonia and 7 more
- Volunteers
- 53 people
- Sponsor
- Shionogi
Complicated Urinary Tract Infection
A Study to Investigate PK, Safety, Tolerability of Cefepime-enmetazobactam in Pediatric Participants With cUTI
This phase 2 study is part of regulatory commitments in the United States (PSP) and Europe (PIP) to evaluate cefepime-enmetazobactam in paediatric participants with cUTI to support extension of the indication for…
- Trial name
- NCT05826990
- Testing
- cefepime and enmetazobactam combination
- Where
- 8 sites in Czechia, France and 4 more
- Volunteers
- 40 people
- Sponsor
- Orchid Pharma Europe GmbH
Complicated Urinary Tract Infection, Acute Pyelonephritis
A Study of Plazomicin Compared With Meropenem for the Treatment of Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis (AP)
This was a randomized, multicenter, multinational, double-blind study comparing the efficacy and safety of plazomicin compared with meropenem followed by optional oral (PO) therapy in the treatment of cUTI, including AP, in…
- Trial name
- EPIC (NCT02486627)
- Testing
- plazomicin, meropenem, levofloxacin (oral)
- Volunteers
- 609 people
- Sponsor
- Achaogen, Inc.
Urinary Tract Infections
POS-cUTI: Study on Complicated Urinary Tract Infections
Urinary tract infections (UTI) are among the most common infectious diseases and the most frequent source of community, healthcare-associated and nosocomial bacteraemia.
- Trial name
- NCT05458700
- Testing
- Collect information
- Where
- Spain
- Volunteers
- 16,000 people
- Sponsor
- European Clinical Research Alliance for Infectious Diseases (ECRAID)
Urinary Tract Infection Symptomatic, Acute Pyelonephritis
Safety and Efficacy of ZTI-01 (IV Fosfomycin) vs Piperacillin/Tazobactam for Treatment cUTI/AP Infections
The purpose of the study is to demonstrate the safety and efficacy of ZTI-01 (IV fosfomycin) as non-inferior to piperacillin/tazobactam in overall success (clinical cure and microbiologic eradication) for the treatment of…
- Conditions
- Urinary Tract Infection Symptomatic, Acute Pyelonephritis, Urinary Tract Infection Complicated
- Trial name
- ZEUS (NCT02753946)
- Testing
- ZTI-01, Piperacillin-tazobactam
- Where
- 68 sites in United States, Belarus and 14 more
- Volunteers
- 465 people
- Sponsor
- Nabriva Therapeutics AG
Complicated Urinary Tract Infection; Cuti
Pharmacokinetics of Benapenem in Subjects With Renal Impairment
This is an open-label, multiple center, parallel-group Study to compare the pharmacokinetics and safety of single-dose benapenem (1.0mg) in subjects with mild or moderate Renal Impairment(RI) and healthy subjects.
- Trial name
- NCT04476407
- Testing
- benapenem
- Where
- China
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Sihuan Pharmaceutical Holdings Group Ltd.
Complicated Urinary Tract Infections
LYS228 PK, Clinical Response, Safety and Tolerability in Patients With Complicated Urinary Tract Infection (cUTI)
The purpose of the study is to evaluate whether LYS228 can be developed for the treatment of complicated urinary tract infections
- Trial name
- NCT03377426
- Testing
- LYS228, Standard of care therapy
- Where
- 5 sites in United States, Denmark and 1 more
- Sponsor
- Novartis Pharmaceuticals